Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial — ATLAS  

Perianal Fistula Clinical Trial

Official title: Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial, a Double-blind, Placebo-controlled, Randomized Trial

Status Recruiting

Clinical Trial Summary

Rationale:

Perianal fistula is a burdening disease with an annual prevalence of 2/100.000 in the Dutch population. More than 90% of crypto-glandular fistulas originate from anorectal abscess. Despite adequate drainage of anorectal abscess up to 83% recurs or results in an anal fistula, the majority developing within 12 months. Up till now it is not common practice to routinely administer prophylactic antibiotics to prevent anal fistula development.\

Objective:

The objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas.

Study design:

The study concerns a double-blind, placebo-controlled, randomized, multicenter trial with treatment of perianal abscess by surgical drainage alone or combined with antibiotic treatment. Patients will be accrued by all participating clinics. The design involves allocation of all appropriate consecutive patients with a primary occurrence of perianal abscess to surgical drainage followed by either antibiotics or placebo. Data will be analyzed on 'intention to treat' basis in case patients are not subjected to the randomized treatment modality.

Study population:

Men and women of 18 years and older who present for the first time with a perianal abscess.

Intervention (if applicable): The antibiotic group receives 7 days of oral metronidazole (500 mg every eight hours) and ciprofloxacin (500 mg every twelve hours) in addition to surgical drainage. The other group receives surgical drainage and postoperatively identical placebo tablets.

Main study parameters/endpoints:

Primary outcome measure is development of a perianal fistula. Secondary outcome measures are quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. Further: in-hospital direct and indirect costs and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

For this study, patients are asked to take part in a study comparing the addition of antibiotic treatment to surgical drainage of perianal abscess. Patients will not be burdened by extra hospital visits. At baseline participants will complete PRO questionnaires. Also at 1 week and 3, 6 and 12 months participants will fulfill the PRO questionnaires. These will be send to them by email and will take approximately 10 minutes each time.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Abscess
• Drain Abscess
• Fistula
• Perianal Abscess
• Perianal Fistula

• NCT number: NCT05385887
• Study type: Interventional
• Source: Proctos Kliniek
• Contact: Ingrid M Han-Geurts, Dr.
• Phone: 030 225 0260
• Email: i.han@proctoskliniek.nl
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2021
• Completion date: August 1, 2025